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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 061969

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NDA 061969 describes CEPHALEXIN, which is a drug marketed by Ajenat Pharms, Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Hikma Pharms, Vitarine, Yung Shin Pharm, and Aurobindo Pharma Ltd, and is included in fifty-one NDAs. It is available from thirty-four suppliers. Additional details are available on the CEPHALEXIN profile page.

The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

Summary for 061969

Tradename:	CEPHALEXIN
Applicant:	Ivax Sub Teva Pharms
Ingredient:	cephalexin
Patents:	0

Medical Subject Heading (MeSH) Categories for 061969

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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